General Information

Job Advert Title: Associate Device Quality Director

Location: Nihonbashi,Tokyo

Division: Quality Assurance

Employment Class: Permanent

Description

【Purpose & Scope】

The Associate Director, Device Quality, reports to the Senior Director, Device Quality and contributes to the development, implementation, and successful execution of the QA mission, objectives and 3-5-year strategic plan. 

This role is responsible for supporting the Quality Management System (QMS) to support the Product Lifecycle management for Astellas Medical Devices and Combination Products.  This role ensures the Astellas QMS medical device elements are maintained globally, which includes central oversight over medical device QMS training, effectiveness checks and internal audits.  Partners with stakeholders to ensure changes and continuous improvements to the quality management system are planned and implemented in accordance with ISO13485, EU MDR 2017/745 and FDA Part 4 requirements.


Essential Job Responsibilities

1.    Responsible for implementing new or revised medical device and combination product QMS requirements. Serves in a leadership role as part of QA. Accountable for integrating process development, improvement and strategy with QA leadership for the medical device and combination product QMS.

2.    Responsible for the analysis and implementation of global medical device and combination product regulations training curriculum which demonstrates compliance with mandatory regulatory requirements. 

3.    Responsible for selecting and partnering with vendors to design and develop medical device and combination product QMS training. 

4.    Responsible for publishing annual internal audit schedule of the Medical Device and Combination Product QMS elements.  Ensure qualified Astellas auditors and/or external contractors are identified to conduct the audits. 

5.    Responsible for vendor contract negotiations with outsourcing partners and ensures compliance with contract terms and conditions in collaboration with Procurement. 

6.    Provides leadership to achieve quality goals, develops and implements an ongoing education program for QMS processes while developing measures to monitor the effectiveness of the QMS itself and drive remediation for improvement.

7.    Responsible for leadership, development and management of an effective and compliant QMS by working closely with all levels of personnel and management across Astellas functions. Provides quality solutions by participating in business activities and initiatives to promote the awareness of quality.

8.    Participates in effective communication forums and presents Quality System Device Quality strategy to Astellas Functions/Divisions. Establishes and promotes positive, timely, and collaborative interactions with all Astellas entities to support the effective and efficient application of the Astellas QMS.

9.    Applies knowledge of the Code of Federal Regulations, ICH Guidelines, ISO standards and other applicable regulations, policies, and procedures for oversight and management of QMS requirements. Interprets new and revised medical device global regulatory requirements to identify, drive, support and/or manage process improvement initiatives to ensure Astellas maintains compliance with medical device regulatory requirements.

10.  Establishes membership in appropriate professional bodies, contacts with peers from respected ethical companies as well as attends relevant meetings and symposia to maintain up-to-date knowledge of industry standards and practices.



【Quantitative Dimensions】

Responsible for contribution to obtain the quality inputs and outputs of Management Review and deliverables for QA related to Medical Devices and Combination Products.  Analyze metrics on an on-going basis (i.e. monthly) in preparation for Management Review.  Provides guidance in driving consistency across the organization.

Functions as the QA main point of contact for all functional areas utilizing the medical device and combination products Quality Management System locally and globally.

QA oversight for global QMS activities to support the development, launch and maintenance of Astellas Products including advanced therapy medicinal products, Medical Devices and Combination Products.



Required

Minimum of a Bachelor of Arts/ Bachelor of Science degree.

・Minimum of 7 years quality assurance experience in the medical device industry

Working knowledge of ISO 13485, EU MDR 2017/745 and FDA Part 4

Minimum of 4 years project management experience, preferably in a multicultural, global setting, requiring facilitation, negotiation, problem-solving, and conflict resolution skills.

・Proficiency in Microsoft Office

Skills and competencies:

Strong interpersonal skills and multi-cultural /intercultural awareness; able to negotiate and build consensus for plans and priorities and able to develop effective relationships through collaboration. Forges strong working relationships with all colleagues and stakeholders.

・Excellent oral and written communication as well as presentation skills.

Demonstrated ability to proactively predict and resolve complex problems, think strategically and tactically, generate solutions to complex problems and build consensus across the global organization. Able to generate insights and leverage learnings at the individual, team and functional level.

Strong planning and organizational skills and experience managing multiple priorities simultaneously.

Strong leadership skills; communicates and demonstrates vision and commitment.

Domestic and international travel of 10-15% is required.


Preferred

Advanced Degree Preferred





【勤務地 / Location

東京都中央区 アステラス製薬 日本橋事業所 本社

Nihonbashi, Tokyo



【勤務開始日 / Start Date

応相談

Will be decided according to the candidate's flexibility



【契約期間 / Contract Duration

期間の定めなし

Not limited to specified period



【試用期間 / Probation Period

試用期間原則なし

No probation period in principle



【給与 / Salary

①基本給:当人の経歴・技術・技能等を考慮して決定

②裁量労働制の場合:裁量労働手当として職務グレードに応じて50,000100,000円支給

③フレックスタイム制の場合:月間の所定労働時間を超えて勤務する時間に対して時間外勤務手当を支給

①Base salary: will be decided by the candidate's experience, skill and capability.

②When Discretionary Work System is applied: Discretionary work allowance will be paid.(50,000~100,000yen, based on the Grade)

③When Flextime System is applied: Overtime allowance will be paid for time worked in excess of prescribed working hours.



【昇給 / Salary Raise

年一回

Once a year



【賞与 / Bonus

2回(7月、12月)

Twice a year (July, December)



【諸手当 / Allowance

裁量労働手当、住宅手当、通勤手当 等

Discretionary work allowance, Housing allowance, Commutation allowance, etc.


 

【勤務時間 / Working Hours

8:45~17:45(月~木)、8:45~16:00(金)、企画業務型 裁量労働制

裁量労働制の場合、所定労働時間を働いたものとみなす

8:45~17:45(Mon~Thu)、8:45~16:00(Fri)

Flex-time system or Discretionary Work System




【休日 / Holidays

完全週休2日制、祝日、51日、夏季、年末年始

Weekends(Sat and Sun), holidays, May 1st, summer vacation, New Year holidays



【休暇 / Vacation Leave

年次有給休暇、育児休業制度、介護休業制度 等

Annual paid leave, childcare leave system, nursing care leave system, etc.



【福利厚生 / Welfare

雇用保険、労災保険、厚生年金、健康保険、共済会制度、社宅制度、持株会制度、財形貯蓄制度 等

Employment Insurance, Industrial Accident Compensation Insurance, Welfare Pension Insurance, Health Insurance, Mutual Aid Association System, Company Housing System, Employee Shareholder Association System, Property Accumulation Savings System



【お問い合わせ / Contact

アステラス製薬株式会社 採用担当 / Japan Recruiting team, Astellas Pharma Inc.

astellas.recruit@jp.astellas.com

※本職種についてのご質問は、上記までお問い合わせください。



"We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law."